FDA Expands Label of Oral HIV Drug to Newborns

The FDA expanded the approval of dolutegravir tablets for oral suspension (Tivicay PD) to include newborns with HIV infections younger than 4 weeks of age, the agency announced on Tuesday.

In combination with other antiretroviral therapies (ARTs), the once-daily treatment is indicated for babies weighing at least 2 kg (~4.4 lbs) who are naive to an integrase strand transfer inhibitor (INSTI).

The approval was supported by the phase I IMPAACT 2023 study and pharmacokinetic modeling data. The open-label trial included 48 newborns who received dolutegravir in addition to standard ART for up to 6 weeks. With 16 weeks of follow-up, data showed that dolutegravir levels among the babies were similar to levels linked to efficacy in adults, along with a safety profile consistent with treatment in older patients.

“For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible,” said investigator Diana Clarke, PharmD, of Boston University School of Medicine, in a press release from manufacturer ViiV Healthcare.

The approval “represents an important advance for the care of newborns, as early treatment with the most effective therapies results in the best possible outcomes,” Clarke noted.

First approved in 2013 for adults and kids 12 years and older, dolutegravir went on to receive an indication for children as young as 4 weeks. The second-generation INSTI is recommended by the World Health Organization as part of first- or second-line ART regimens for children living with HIV.

Of note, dolutegravir tablets for adults aren’t bioequivalent with the oral suspension tablets for kids and can’t be substituted on a mg-per-mg basis, the FDA cautioned.

The most common moderate to severe adverse events, occurring in at least 2% of adult study participants, included insomnia, fatigue, and headache.

Contraindications noted in the drug’s labeling include coadministration with dofetilide and previous allergic reactions to dolutegravir. Hypersensitivity reactions including rash and liver injury have been reported. Some patients taking combination ART regimens have reported immune reconstitution syndrome.